LymphomaPhase 1/2NCT00572013
Rituxan and BEAM With Autologous Peripheral Blood Progenitor Transplant for Indolent Lymphoma
A Phase 1/2 study testing Rituxan, BEAM and Autologous stem cell transplant in people with Lymphoma, run by University of Nebraska at 1 site in United States.
Trial summary
To determine the response rate, complete and partial, of patients with indolent lymphoma receiving Rituxan and BEAM with autologous stem cell transplant. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Rituxan, BEAM and Autologous stem cell transplant
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 1998to 18 Sep 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any low-grade B-cell, CD20 positive, non-Hodgkin's lymphoma that is felt to otherwise be a transplant candidate (relapsed, induction failure, first PR or CR).
- o Small lymphocytic, marginal zone, mantle cell, and follicular histologies.
- At least 19 years of age
- Signed written informed consent
- Expected survival of at least 6 months
- WHO performance status greater or equal to 2
- Male or female subjects of reproductive potential who are able to follow accepted birth control measures.
Who cannot join
- No history of T-cell lymphoma
- Not pregnant or lactating women
- No serious disease or condition that, in the opinion of the investigator, would compromise the subject's ability to participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center, Section of Oncology/Hematology
Omaha, Nebraska, 68198
About this study
Official title: A Phase I/II Trial of Rituxan and BEAM High-Dose Chemotherapy and Autologous Peripheral Blood Progenitor Transplant for Indolent Lymphoma
To determine the response rate, complete and partial, of patients with indolent lymphoma receiving Rituxan and BEAM with autologous stem cell transplant.
Read the detailed description
Objectives: I. To determine the response rate, complete and partial, of patients with indolent lymphoma receiving Rituxan and BEAM with autologous stem cell transplant. II. To determine if the addition of Rituxan changes the toxicity profile attributed to high-dose BEAM chemotherapy.
This protocol is a phase I/II trial combining the Rituxan as a pre and post-transplant agent to aid in the chemotherapy sensitization and the treatment of minimal residual disease post-transplant.
- Conditions
- Lymphoma
- Being tested
- Rituxan, BEAM, Autologous stem cell transplant
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituxanDrug
Also called Rituximab
375mg/m2 IV on days -20 to -8. Infusion to begin at rate of 50mg/hour for 1st hour.If no toxicity rate may be increased. A second infusion 375mg/m2 given 30days post transplant and again at 60 days post transplant
BEAMDrug
BCNU(carmustine)on day -6 300mg/M2 IV, etoposide 100mg/M2 BID on days -5 through -2, cytarabine 100mg/m2 BID on days -5 through -2, melphalan 140mg/m2 IV on day -1
Autologous stem cell transplantProcedure or surgery
following chemotherapy, on day 0 of treatment, the previously stored hematopoietic stem cells will be reinfused via the central venous line
| Study group | Role | What they receive |
|---|---|---|
| Arm I Rituxan and BEAM post-autologous stem cell transplant | Experimental | Rituxan and BEAM [Carmustine (BCNU), Etoposide, Cytarabine (Ara-C, cytosine arabinoside), Melphalan] will be a pre- and post-transplant agent to aid in the chemotherapy sensitization post-autologous stem cell transplant. Receives: Drug: Rituxan; Drug: BEAM; Procedure: Autologous stem cell transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Disease response at day 100
Measured: 100 day
Secondary outcomes (1)
Overall survival
Survival time from diagnosis until death
Measured: diagnosis until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study start12 May 1998
- Primary completion1 Jan 2001
- Study completion18 Sep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie M Vose, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572013
- Sponsor's protocol ID
- 0138-98-FB
- Status last verified
- Sep 2023
- First submitted
- 11 Dec 2007
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Rituxan and BEAM High-Dose Chemotherapy and Autologous Peripheral Blood Progenitor Transplant for Indolent Lymphoma
- ClinicalTrials.gov ID
- NCT00572013
- Acronym / sponsor ID
- 0138-98-FB
- Conditions
- Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 12 May 1998 (actual)
- Primary completion
- 1 Jan 2001 (actual)
- Study completion
- 18 Sep 2009 (actual)
- First posted
- 12 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the response rate, complete and partial, of patients with indolent lymphoma receiving Rituxan and BEAM with autologous stem cell transplant.
Detailed description
Objectives: I. To determine the response rate, complete and partial, of patients with indolent lymphoma receiving Rituxan and BEAM with autologous stem cell transplant. II. To determine if the addition of Rituxan changes the toxicity profile attributed to high-dose BEAM chemotherapy.
This protocol is a phase I/II trial combining the Rituxan as a pre and post-transplant agent to aid in the chemotherapy sensitization and the treatment of minimal residual disease post-transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I Rituxan and BEAM post-autologous stem cell transplant | Experimental | Drug: Rituxan, Drug: BEAM, Procedure: Autologous stem cell transplantRituxan and BEAM [Carmustine (BCNU), Etoposide, Cytarabine (Ara-C, cytosine arabinoside), Melphalan] will be a pre- and post-transplant agent to aid in the chemotherapy sensitization post-autologous stem cell transplant. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Any low-grade B-cell, CD20 positive, non-Hodgkin's lymphoma that is felt to otherwise be a transplant candidate (relapsed, induction failure, first PR or CR).
- o Small lymphocytic, marginal zone, mantle cell, and follicular histologies.
- At least 19 years of age
- Signed written informed consent
- Expected survival of at least 6 months
Key exclusion criteria (3 listed)
- No history of T-cell lymphoma
- Not pregnant or lactating women
- No serious disease or condition that, in the opinion of the investigator, would compromise the subject's ability to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituxanAlso: Rituximab375mg/m2 IV on days -20 to -8. Infusion to begin at rate of 50mg/hour for 1st hour.If no toxicity rate may be increased. A second infusion 375mg/m2 given 30days post transplant and again at 60 days post transplant | Drug | Arm I Rituxan and BEAM post-autologous stem cell transplant |
| BEAMBCNU(carmustine)on day -6 300mg/M2 IV, etoposide 100mg/M2 BID on days -5 through -2, cytarabine 100mg/m2 BID on days -5 through -2, melphalan 140mg/m2 IV on day -1 | Drug | Arm I Rituxan and BEAM post-autologous stem cell transplant |
| Autologous stem cell transplantfollowing chemotherapy, on day 0 of treatment, the previously stored hematopoietic stem cells will be reinfused via the central venous line | Procedure or surgery | Arm I Rituxan and BEAM post-autologous stem cell transplant |
Primary outcome
Response rate
Time frame: 100 day
Disease response at day 100
1 secondary outcome
Overall survival
Time frame: diagnosis until death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie M Vose, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rituxan, BEAM and Autologous stem cell transplant in people with Lymphoma, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 100 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.